Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section

Postoperative Nausea and Vomiting Clinical Trial

— POC-NaVoP  

Official title:

An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04069806
• Other study ID #: PUM_08.08.2019
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2020
• Source: Pomeranian Medical University Szczecin
• Contact: Katarzyna L Kotfis, MD, PhD
• Phone: 0048914661144
• Email: katarzyna.kotfis[@]pum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. The aim of this study is to compare the effectiveness of oral carbohydrate loading to standard pre-operative fasting in patients undergoing elective cesarean section on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Description:

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. Known mechanisms underlying PONV are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. However, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. An analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. The aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >=18 years.

2. Scheduled for an elective cesarean section.

3. Uncomplicated pregnancy.

4. Planned for spinal anesthesia.

5. ASA I or ASA II.

Exclusion Criteria:

1. History of diabetes.

2. History of gastro-intestinal reflux (GERD).

3. Unable or unwilling to sign an informed consent.

4. Contraindications to spinal anesthesia.

5. Contraindication to Oral carbohydrate formula.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Dietary Supplement:
• preoperative oral carbohydrate, preOp
Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomiting 6 hours after caesarian section.	The Postoperative Nausea and Vomiting (PONV) Intensity Scale 6 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score =50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).	6 hours
Primary	Postoperative nausea and vomiting 24 hours after caesarian section.	The Postoperative Nausea and Vomiting (PONV) Intensity Scale 24 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score =50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).	24 hours
Secondary	Time to first peristalsis.	Moment of first peristalsis after operation (in hours).	24 hours
Secondary	Time to first bowel movement.	Moment of first bowel movement after operation (in hours).	24 hours
Secondary	Concentration of serum lactate in serum.	Lactate level measured in maternal serum.	0 hours
Secondary	Concentration of beta-hydroxy-butiric acid in serum.	Beta-hydroxy-butiric acid level measured in maternal serum.	0 hours
Secondary	Insulin resistance factor (HOMA-IR).	Insulin resistance measured in maternal serum.	0 hours
Secondary	Concentration of isoprostane in urine.	Isoprostane level measured in maternal urine.	0 hours